Duns Number:080216804
Device Description: Adapt O-Life Aerosol Tee Adapter Spring Loaded Valved 15mm I.D. x 15mm O.D. The Tee piece Adapt O-Life Aerosol Tee Adapter Spring Loaded Valved 15mm I.D. x 15mm O.D. The Tee piece connector is designed for connecting to the patient port of the respiratory or anesthesia breathing circuit, or connecting nebulizer and corrugate tube or mouth piece.
Catalog Number
RTG-07202
Brand Name
Adapt O-Life
Version/Model Number
RTG-07202
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
6a598056-2e33-44c0-b1a9-242bf1779d42
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
February 25, 2019
Package DI Number
10853292007540
Quantity per Package
30
Contains DI Package
00853292007543
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |